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Ketamine alone for Cataract

Phase 2
Waitlist Available
Research Sponsored by Melt Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
1. Are to undergo unilateral primary uncomplicated CELR under topical anesthesia, with a phacoemulsification device and insertion of an intraocular lens.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-operatively (at baseline), intra-operatively post-operatively on day 1, on the day after surgery (day 2, via a phone call), and at 1 week (day 8 ± 2 days) after dose of study medication
Awards & highlights

Study Summary

This trial is testing a new drug for safety and effectiveness in people getting cataract surgery.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after study medication administration before surgery (baseline) and intraoperatively
This trial's timeline: 3 weeks for screening, Varies for treatment, and after study medication administration before surgery (baseline) and intraoperatively for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean Intraoperative Analgesia as Measured by the Numeric Pain Rating Scale
Percentage of Participants with Success for Procedural Sedation by Using Ramsay Sedation Scale
Secondary outcome measures
Number of Participants Reported with At least One Treatment Emergent Adverse Event (TEAE)
Number of Participants with Pain Scores
Number of Participants with Sedation Scores
+7 more
Other outcome measures
Participant Likelihood of Wanting Study Drug Again for Second Cataract Surgery as Measured by 11-point Likert Scale
Percentage of Participants with Concomitant Medication Opioid Use and Average Opioid Consumption
Postoperative Pain as measured by the Numeric Pain Rating Scale Scores

Trial Design

4Treatment groups
Active Control
Placebo Group
Group I: Ketamine aloneActive Control1 Intervention
Participants will receive a single dose of ketamine 50 mg sublingual tablet.
Group II: MELT-300Active Control1 Intervention
Participants will receive a single dose of MELT-300 sublingual, rapidly dissolving tablet containing 3 mg of midazolam and 50 mg of ketamine.
Group III: Midazolam aloneActive Control1 Intervention
Participants will receive a single dose of midazolam 3 mg sublingual tablet.
Group IV: PlaceboPlacebo Group1 Intervention
Participants will receive a single dose of a matching placebo sublingual tablet.

Find a Location

Who is running the clinical trial?

Melt PharmaceuticalsLead Sponsor
2 Previous Clinical Trials
42 Total Patients Enrolled
Worldwide Clinical TrialsOTHER
61 Previous Clinical Trials
14,049 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study of MELT-300 (Midazolam and Ketamine Sublingual Tablets) for Sedation and Intraoperative Ocular Analgesia in Participants Undergoing Cataract Extraction With Lens Replacement (CELR)
2021. "A Study of MELT-300 (Midazolam and Ketamine Sublingual Tablets) for Sedation and Intraoperative Ocular Analgesia in Participants Undergoing Cataract Extraction With Lens Replacement (CELR)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05133518.
~90 spots leftby Apr 2025
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